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FDA 510(k)

ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES

K-Number: K965156 · 1997-01-24

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1997-01-24
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1997-01-24 under 510(k) number K965156. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES?

ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K965156.

When did ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES receive FDA 510(k) clearance?

ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES received FDA 510(k) clearance on 1997-01-24, under 510(k) number K965156.

Who is the listed applicant for ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES?

The FDA 510(k) record lists Johnson & Johnson Professionals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES?

The FDA product code for ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES is KWL.

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Related Devices (Code: KWL)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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